2020 will go down in the books as the year COVID-19 changed everything. Virtually no industry was untouched. Some benefited, but many did not.
As a packaging OEM with a medical device practice that includes syringe, test kit and PPE packaging, we've had a front row seat to Operation WARP Speed. Medical device producers, scrambling to deliver equipment to front-line workers under previously unheard-of time pressure, have had to press the envelope of traditional packaging approaches. Little can be done in that time frame to accelerate the production of new packaging machines. Instead, producers have looked to work arounds and embraced changing customer requirements to meet that demand.
We’ll focus our discussion in three areas that have made a difference in the short run: alternative packaging methods employed, automation, and individual versus bulk product packaging.
Alternative Packaging Methods Employed
One of the key objectives of Operation Warp Speed has been ensuring syringe availability as the vaccination effort scales. This creates pressure on manufacturers to ensure ongoing availability for standard syringe use in healthcare settings.
There are five primary versions of syringes, each with defined applications and different levels of packaging depending on their use. All syringes are subject to strict sterilization requirements, but packaging requirements vary by intended use case. That’s because packaging can increase, or diminish, a healthcare worker’s ability to use the product in sterile fashion.
For example, syringes used for subcutaneous injection present lower risk in field use and are therefore typically packaged in bulk using flow wrap packaging.
Meanwhile, syringes destined for intramuscular/surgical applications are packaged for specific sterile environments, the most stringent of which dictate additional sterilization using ETO – ethylene oxide, ethylene chlorohydrin and ethylene glycol. Such syringes are almost always packaged individually using a thermoformed package. That’s because thermoforming (which uses a TFS machine) produces a formed pocket – making it easier to maintain strict sterility during the peeling/opening process as well as avoiding package punctures or compromises. It also provides a greater surface area for printed instructions on the packaging itself (labeling must define approved drugs and use cases).
Thermoforming has been the traditional, institutional preference for packaging anything other than subcutaneous syringes. This has been primarily due to the sheer simplicity of being able to use the same products across a wider variety of use cases.
However, flow wrap packaging offers an alternative in less stringent use cases. While a flow wrapper can’t offer the same overall throughput as a TFS machine, they are more readily available, typically at lower cost. Of course, this approach can increase the risk to maintain sterility in the field as a package is opened. Staff have to carefully remove the wrapping to access the product without compromising sterility. But the current difference between demand and supply provides ample justification for employing these methods in non-surgical syringe use cases, and even in COVID-19 test kits, where a small vial and swab are packaged together. While there is no difference in inherent product sterility, the onus falls to front-line healthcare workers for proper application.
In general, people intuitively understand that automation performs faster and more accurately than humans. No surprise there. What may be more surprising is how many medical device producers still rely on humans to load, transfer, unload, and case pack in high volume production environments.
While the COVID-19’s impact on the food production industry labor pool (meat packing in particular) was very public, every producer that was not 100% automated felt the pinch. COVID accentuated long standing issues with producer reliance on a shrinking manufacturing labor pool. The result has been an acceleration of planned automation investments on the front and back ends of medical device packaging, which we believe will survive well into the post-COVID era.
When making the decision to automate, simple payback is the typical criteria – usually in 12-18 months. What COVID did was raise the risk and uncertainty of human labor to a significantly less acceptable degree. A long-time customer who used manual loading for two syringe thermoforming machines for the last 15 years made the decision to automate product loading and case packing in 2020. The only change? COVID-19.
If your organization is seeking to permanently reduce the risks associated with manned packaging operations, keep in mind that your automation design and investment will be tied to the packaging method you employ.
Thermoformers can produce a lot of throughput at a slower cycle speed because they are designed to process as many as 50 products at a time in parallel. A flow-wrapper uses a serial process that aligns and feeds product one at a time, requiring it to run at a much higher cycle time to generate the same throughput. The feeding and robotic placement, as well as the back end case packing will be different for each.
Individual vs Bulk Product Packaging
At the heart of the fight against COVID-19 are the front-line workers who work long and exhausting hours administering aid to millions of patients while putting themselves at risk for exposure. While vaccines are now being administered to healthcare workers, there remains a monumental demand for personal protective gear (PPE’s) which will not subside for the foreseeable future. Non-surgical masks, gloves, glasses, shields, and gowns are all essential PPE’s for front-line workers.
Until COVID-19, some products such as eye protection and gowns were envisioned by healthcare institutions as disposable, single-use items, and packaged individually. While the higher level of sterility such packaging offers is still appropriate for surgical environments, institutions are now accepting of bulk packaging techniques that allow for higher speed packaging and therefore better availability.
Similar to syringes, sticking to a single approach offered healthcare organizations simplicity and flexibility of inventory management and distribution. As severe shortages drove re-wear and DIY substitutions, it made little sense to maintain the practice of individualized packaging for PPE such as gowns, shields, and protective eyewear. These are now produced in bulk packaging formats, accelerating the production process and helping to swell the pipeline of PPE at a critical time.
The opposite has happened for masks. Prior to the pandemic, they were bulk packaged but new retail demands for individual masks actually increased such packaging for point-of-sale applications.
Will the post-COVID production environment resemble pre-COVID times, or will it leave an indelible mark on medical device production?
At Harpak-ULMA we believe the old proverb “once bitten twice shy” will characterize this market for the foreseeable future. The changes that are taking place as a result of necessity are reshaping producer (and even government regulators') risk tolerance and generating new expectations for disposable medical device packaging.
Producers will likely continue to add improved production flexibility and capability for months or even years in anticipation of future shock. But recognizing that there are alternatives to long-held packaging preconceptions may change how they get there.